OBJECTIVES: This study systematically analyzes adverse events (AE) associated with these JAK inhibitors, reported in the FDA's Adverse Event Reporting System (FAERS), to inform clinical decision-making and patient care.

METHODS: A descriptive retrospective analysis of FAERS data (2012 to 2022) was conducted. All AE reports associated with JAK inhibitors were extracted to calculate the case patient demographics, indications, and most frequent AE reports. The analysis categorized events and identified annual trends to assess their safety profiles. Reporting Odds Ratio (ROR) was conducted to assess the key safety signals.

RESULTS: The analysis showed notable usage of all three drugs, peaking in 2022 with over 35,000, 1,500, and 16,000 patients' cases for Xeljanz, Olumiant, and Rinvoq, respectively. Females used these drugs predominantly (79.28% for Xeljanz, 71.32% for Olumiant, 75.18% for Rinvoq). Adverse event reporting surged at 41,679 reports in 2020 for Xeljanz, 1,751 in 2021 for Olumiant, and 17,648 in 2022 for Rinvoq, with common adverse events including respiratory diseases, arthralgia, cancer, and cardiovascular diseases. While RA was the primary indication, there was considerable off-label use and treatment for conditions like psoriasis and colitis ulcerative. The key safety signals of ROR for Xeljanz are 1.0593 for respiratory diseases, 1.7725 for arthralgia, 0.6752 for cardiovascular diseases, 0.3459 for cancer. For Olumiant the ROR were 1.3132 for respiratory diseases, 0.1317 for arthralgia, 1.2587 for cardiovascular diseases, 2.8026 for cancer. Finally, Rinvoq’ RORs included 0.839 for respiratory diseases, 0.7098 for arthralgia, 1.5003 for cardiovascular diseases, and 2.5102 for cancer.

CONCLUSIONS: